FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
M015 OXYGEN & MA15 AIR
K Number: K791900
·
Decision Oct 11, 1979
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
23
Applicant Total
29
Review Days
16
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Basic Information
- Device Name
- M015 OXYGEN & MA15 AIR
- K Number
- K791900
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.2340
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Timeter Instrument Corp.
- Date Received
- September 25, 1979
- Decision Date
- October 11, 1979
- Product Code
- CAX
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CAX | Flowmeter, Tube, Thorpe, Back-Pressure Compensated | FDA class 1 | Anesthesiology |
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Other Clearances by Timeter Instrument Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K875075 | RT-200 COMPUTER INTERFACE | Apr 21, 1988 | Substantially Equivalent |
| K875074 | VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000 | Feb 22, 1988 | Substantially Equivalent |
| K871603 | CRITERION II & IIA OXYGEN CONCENTRATORS | Aug 13, 1987 | Substantially Equivalent |
| K864836 | L.A.P. SPIROMETER | Mar 6, 1987 | Substantially Equivalent |
| K834274 | CRITERION I | Apr 13, 1984 | Substantially Equivalent |
| K823775 | BORDON GAGE REGULATOR #BG | Jan 14, 1983 | Substantially Equivalent |
| K822746 | RT-200 CALIBRATION ANALYZER | Oct 13, 1982 | Substantially Equivalent |
| K812766 | PCS-5 ACCESSORIES | Dec 17, 1981 | Substantially Equivalent |
| K813235 | DISS FEMALE AIR ADAPTOR | Dec 8, 1981 | Substantially Equivalent |
| K813234 | OHIO AIR ADAPTOR | Dec 8, 1981 | Substantially Equivalent |